Ramipril CINFA 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ramipril cinfa 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What ramipril cinfa is and what it is used for
2. What you need to know before taking ramipril cinfa
3. How to take ramipril cinfa
4. Possible adverse effects
5. How to store ramipril cinfa
6. Contents of the pack and other information

1. What is ramipril cinfa and what is it used for

ramipril cinfa contains an active substance called ramipril. This belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).

ramipril cinfa works as follows:

• By reducing the body's production of substances that could increase blood pressure.
• By relaxing and widening blood vessels.
• By making it easier for the heart to pump blood around the body.

ramipril cinfa can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes).
• To treat heart failure (when the heart cannot pump enough blood to the rest of the body).
• As treatment after a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before taking ramipril cinfa

Do not take ramipril cinfa

• If you are allergic to ramipril, to any other ACE inhibitor medicine, or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

• If you have ever had a severe allergic reaction called “angioedema.” Symptoms include itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is high.

• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, ramipril cinfa may not be suitable for you.

• If you have kidney problems where blood supply to the kidneys is reduced (renal artery stenosis).

• During the last 6 months of pregnancy (see the section “Pregnancy and breastfeeding” below).

• If your blood pressure is abnormally low or unstable. This assessment must be made by your doctor.

• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

• If you are taking any of the following medicines, as the risk of developing angioedema may increase:

• Racecadotril, a medicine used to treat diarrhoea.

• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

• Vildagliptin, a medicine used to treat diabetes.

Do not take ramipril cinfa if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking ramipril cinfa.

Warnings and precautions

Talk to your doctor or pharmacist before taking ramipril cinfa:

• If you have heart, liver, or kidney problems.

• If you have lost large amounts of salts or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets), or dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitisation).

• If you are going to receive an anaesthetic. This may be given during surgery or dental procedures. You may need to stop treatment one day before; consult your doctor.

• If you have high levels of potassium in your blood (shown in blood test results).

• If you are taking medicines or have a disease that may reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.

• If you are taking any of the following medicines, as they increase the risk of angioedema (rapid swelling under the skin, such as in the throat):

• Temsirolimus, sirolimus, everolimus and other medicines belonging to the mTOR inhibitor class (used to prevent rejection of transplanted organs), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 "Do not take ramipril cinfa".

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.

• You must inform your doctor if you suspect you are (or could become) pregnant. ramipril cinfa is not recommended during the first three months of pregnancy and may cause serious harm to the baby if used after the third month of pregnancy (see section “Pregnancy and breastfeeding” below).

• If you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take ramipril cinfa”.

Children and adolescents

The use of ramipril cinfa is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of ramipril have not yet been established in children.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking ramipril cinfa.

Other medicines and ramipril cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, as ramipril cinfa may affect how these medicines work. Likewise, some medicines may affect how ramipril cinfa works.

Inform your doctor if you are taking any of the following medicines, which may make ramipril cinfa less effective:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to check your blood pressure.

Inform your doctor if you are taking any of the following medicines, as they may increase the likelihood of side effects when combined with ramipril cinfa:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 "Do not take ramipril cinfa").
• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacina, and aspirin).
• Medicines for cancer treatment (chemotherapy).
• Medicines to prevent organ rejection after transplantation such as cyclosporine.
• Diuretics (water tablets) such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to lower uric acid in blood).
• Procainamide (to treat heart rhythm problems).
• Temsirolimus (for cancer treatment).
• Medicines often used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class). See section “Warnings and precautions”.
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhoea).
• Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take ramipril cinfa” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medicines. Their effect may be affected by ramipril cinfa:

• Medicines for diabetes such as glucose-lowering medicines and insulin. ramipril cinfa may reduce blood sugar levels. Monitor your blood sugar levels closely while taking ramipril cinfa.
• Lithium (for treating mental health conditions). ramipril cinfa may increase lithium levels in blood. Your doctor will monitor your blood lithium levels closely.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking ramipril cinfa.

Taking ramipril cinfa with food and alcohol

• Drinking alcohol while taking ramipril cinfa may cause dizziness or lightheadedness. If you are concerned about how much alcohol you can drink while taking ramipril cinfa, talk to your doctor, as combining blood pressure-lowering medicines with alcohol may have additive effects.
• ramipril cinfa may be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Talk to your doctor if you think you may be (or could become) pregnant. You should not take ramipril cinfa during the first 12 weeks of pregnancy, and you must not take it after week 13, as its use during pregnancy could harm the unborn baby.

If you become pregnant while taking ramipril cinfa, inform your doctor immediately. A switch to an appropriate alternative treatment should be made before a planned pregnancy.

Breastfeeding

Do not take ramipril cinfa if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy while taking ramipril cinfa, especially when starting treatment or increasing the dose. If this occurs, do not drive or operate tools or machinery.

Ramipril cinfa tablets contain lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Ramipril cinfa tablets contain sodium: This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take ramipril cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

ramipril cinfa 5 mg tablets:

This strength is not suitable for doses below 2.5 mg.

Dosage

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose you need until your blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are already taking diuretics (water tablets), your doctor may stop or reduce the dose of your diuretic before starting treatment with ramipril cinfa.

To reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Afterwards, your doctor may decide to increase your dose.
• The usual dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney problems

• The starting dose may be 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust your dose.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust your dose.
• The maximum dose is 10 mg per day. It is preferable to take it twice daily.

Treatment after having had a heart attack

• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose.
• The usual dose is 10 mg per day. It is preferable to take it twice daily.

Elderly patients

Your doctor will reduce the initial dose and adjust your treatment more slowly.

How to take this medicine

• Take this medicine orally at the same time each day.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets.

If you take more ramipril cinfa than you should

Contact your doctor immediately or go to the nearest hospital emergency department. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 915620420, indicating the medicine and the amount ingested.

Do not drive to the hospital; have someone drive you or call an ambulance. Take the medicine packaging with you so the doctor knows which medicine you have taken.

If you forget to take ramipril cinfa

• If you forget to take a dose, take your next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking ramipril cinfa and go immediately to a doctor if you notice any of the following serious adverse effects; you may need urgent medical treatment:

• Swelling of the face, lips, or throat, which may make swallowing or breathing difficult, as well as itching and rash. These could be symptoms of a serious allergic reaction to ramipril cinfa.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or forceful heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These could be symptoms of lung problems.
• Easy bruising, bleeding lasting longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, or infections occurring more frequently than usual, sore throat and fever, feeling tired, fainting, dizziness, or pale skin. These could be symptoms of blood or bone marrow problems.
• Severe stomach pain that may extend to the back. This could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (feeling like vomiting), yellowing of the skin or eyes (jaundice). These could be symptoms of liver problems such as hepatitis (liver inflammation) or liver damage.

Other adverse effects include:

Tell your doctor if any of the following symptoms worsen or last longer than a few days.

Common (may affect up to 1 in 10 people)

• Headache or feeling tired.
• Dizziness. This is more likely to occur when starting treatment with ramipril cinfa or when switching to a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly.
• Dry, irritating cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling or being sick.
• Skin rash, with or without raised areas.
• Chest pain.
• Muscle cramps or muscle pain.
• Blood tests showing higher potassium levels than normal.

Uncommon (may affect up to 1 in 100 people)

• Balance problems (dizziness).
• Itching and abnormal skin sensations such as numbness, tingling, prickling, burning, or chills on the skin (paresthesia).
• Loss or changes in taste.
• Trouble sleeping.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Abdominal swelling known as “intestinal angioedema,” with symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Urinating more frequently than normal during the day.
• Sweating more than normal.
• Loss or decrease in appetite (anorexia).
• Increased or irregular heartbeat.
• Swelling in arms and legs. This may be a sign that your body is retaining more fluid than normal.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased sex drive in men or women.
• Increased number of white blood cells (eosinophilia) found during a blood test.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.

Rare (may affect up to 1 in 1,000 people)

• Feeling unsteady or confused.
• Redness and swelling of the tongue.
• Severe skin scaling or peeling, rash, lumps, itching.
• Nail problems (e.g., nail loss or separation of the nail from its bed).
• Rash or bruising on the skin.
• Skin redness and cold extremities.
• Redness, itching, swelling, or watering of the eyes.
• Hearing disturbances and ringing in the ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells, white blood cells, platelets, or hemoglobin.

Very rare (may affect up to 1 in 10,000 people)

• Increased sensitivity to sunlight.

Other reported adverse effects:

Tell your doctor if any of the following symptoms worsen or last longer than a few days.

• Difficulty concentrating.
• Mouth inflammation.
• Blood tests show very low numbers of blood cells.
• Blood tests show lower than normal sodium levels in blood.
• Concentrated urine (dark-colored), feeling or being sick, muscle cramps, confusion, and seizures, which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Fingers of hands and feet change color in cold conditions, and you feel tingling or pain when they warm up (Raynaud's phenomenon).
• Enlargement of the breast in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ramipril cinfa

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Keep the HDPE bottle tightly closed to protect the medicine from moisture.

Do not use this medicine after the expiry date stated on the packaging, label of the bottle or blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ramipril cinfa

The active substance is ramipril. Each tablet contains 5 mg of ramipril.

• The other components are pregelatinized corn starch, monohydrate lactose, sodium hydrogen carbonate (E500), sodium croscarmellose (E468), red iron oxide (E172), and sodium stearyl fumarate.

Appearance of the product and contents of the pack

ramipril cinfa 5 mg tablets:

Pinkish, mottled, uncoated tablets, cylindrical, 6 mm in diameter, with flat bevelled edges, marked with the letter “H” and the number “19” separated by a score line on one side, and plain on the other side. The tablet can be divided into two equal doses.

Ramipril cinfa tablets are available in:

Blister packs (transparent PVC/Aluminum).

White opaque HDPE bottles with PP screw cap.

Pack Sizes:

ramipril cinfa 5 mg tablets:

Blister: 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100 and 500 tablets

HDPE bottle: 30 and 1,000 tablets (hospital pack)

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

Galenicum Health S.L.U

Calle San Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate,

Hal Far BBG 3000

(Birzebbugia) - Malta

Or

Generis Farmacêutica, S.A.,

Rua João de Deus, n.o 19,

Venda Nova, 2700-487

Amadora, Portugal.

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark Ramipril Aurobindo

Spain Ramipril Cinfa 5 mg tablets EFG

Finland Ramipril Orion 5 mg tablet

France RAMIPRIL ARROW LAB 5 mg, comprimé sécable

Greece RAMISYN 5 mg δισκ?α

Netherlands Ramipril Aurobindo 5 mg, tabletten

Italy Ramipril Aurobindo 5 mg compresse

Malta Ramipril Aurobindo 5 mg tablets

Romania Ramipril Aurobindo 5 mg comprimate

Sweden Ramipril Aurobindo 5 mg tabletter

Date of the most recent review of this leaflet: July 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72289/P_72289.html

QR code to: https://cima.aemps.es/cima/dochtml/p/72289/P_72289.html